Cold and Flu Daytime Relief

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, nasal congestion, headache, minor aches and pains, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours as needed. For children aged 6 to under 12 years, the appropriate dosage is 15 mL every 4 hours.

It is imperative that the total number of doses does not exceed 4 doses within a 24-hour period. Healthcare professionals should advise patients to use only the dose cup provided to ensure accurate measurement and administration.

The product is not recommended for use in children under 6 years of age. Patients should be cautioned against exceeding the directed dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, seek guidance from a healthcare professional.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in the same timeframe. Caution is advised when this product is taken concurrently with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Before recommending this product, it is essential to inquire about the patient's medical history. Users should consult a healthcare provider if they have difficulty urinating due to prostate enlargement, a cough associated with excessive phlegm, a persistent or chronic cough (such as that seen in smoking, asthma, or emphysema), heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other reasons to stop use include worsening fever lasting more than three days, the presence of redness or swelling, the emergence of new symptoms, or if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. A return of cough accompanied by rash or headache that lasts warrants immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if an adult takes more than 4,000 mg of acetaminophen in 24 hours, if a child takes more than 5 doses in 24 hours, if the product is taken with other drugs containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt medical consultation.

It is recommended that patients stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults. A cough that recurs or occurs with a rash or headache that lasts may indicate a serious condition and should be evaluated by a healthcare professional.

Before using this product, patients should consult a doctor if they have difficulty urinating due to prostate enlargement, a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, heart disease, diabetes, thyroid disease, liver disease, or high blood pressure.

Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Daytime Relief (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older may receive this medication at a dosage of 15 mL every 4 hours. For adults and children 12 years and older, the recommended dosage is 30 mL every 4 hours. The use of this medication is not recommended for children under 6 years of age.

Healthcare professionals should be aware that administering more than 5 doses within a 24-hour period may result in severe liver damage. It is crucial to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised that this product contains acetaminophen, which carries a risk of severe liver damage. The risk is particularly heightened under the following circumstances: if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than 5 doses in 24 hours, if the product is used concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease to consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects associated with acetaminophen use.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. They should also be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if a patient's fever worsens or persists for more than three days, they should stop using the medication and seek medical advice.

It is important for patients to stop use and consult a healthcare professional if they notice any redness or swelling, or if new symptoms arise. Patients should also be advised to discontinue use and contact a doctor if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. If a cough returns or occurs alongside a rash or persistent headache, patients should seek medical attention, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have difficulty urinating due to an enlarged prostate gland, a cough accompanied by excessive phlegm, or a persistent or chronic cough related to smoking, asthma, or emphysema. Patients with heart disease, diabetes, thyroid disease, liver disease, or high blood pressure should also be advised to seek medical guidance prior to use.

Finally, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients regarding the use of the medication during pregnancy or breastfeeding, recommending that they consult a health professional prior to use. Additionally, resources are available for understanding the risks of medicine abuse among teens, specifically at www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cold and Flu Daytime Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)